The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations. Individuals working in pharmaceutical sterile ...

Quality by design is critical for cell and gene therapy manufacturing where process controls directly influence product ...

Intel (INTC) provided an update on its foundry business on Tuesday, saying Intel 18A-P has entered risk production on schedule, underscoring the company's efforts to advance its manufacturing ...

In-silico design facilitates process optimization and evaluation of process control strategies. The pharmaceutical industry has recognized the value of implementing a systematic approach to drug ...

Turning 3-dimensional product models into manufacturing process designs is no easy task. Kevin Marseilles, senior process designer with Delphi Corp.’s Saginaw Steering Systems Division, used to spend ...

Once upon a time, integrated circuits (ICs) were built by the same companies that designed them. The design of an IC was tightly integrated with the manufacturing processes available within each ...

The past decade has seen unparalleled growth in the field of cell therapy, which uses cells as therapeutic agents to treat and cure disease. Although the first transplants of blood stem cells date ...